Chrom-Cobalt 95H25

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MEAAxxxx(x)(ww)

by Zirkonzahn GmbH

Identity

Trade Name: CHROM-COBALT EUDAMED
Chrom-Cobalt 95H25 FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: Dental Metal Blanks EUDAMED
Content: 1 piece Height: 25 mm Metal for metal frameworks for veneering with ceramics FDA UDI
Model / Reference: MEAAxxxx(x)(ww) EUDAMED
MEAA0125 FDA UDI
Description: Content: 1 piece Height: 25 mm Metal for metal frameworks for veneering with ceramics FDA UDI

Identifiers

Primary DI / UDI-DI: D800MEAAxxxx(x)(ww)0 EUDAMED
D800MEAA0125 FDA UDI
Basic UDI-DI: ++D800COC0010013Y EUDAMED
Direct Marketing DI: D800MEAAxxxx(x)(ww)0 EUDAMED
FDA Product Code: EJH FDA UDI
EMDN Code: Q01020602 COMBINED DENTAL PROSTHESES EUDAMED
GMDN Term: Dental bridge, metal-ceramic FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.3710 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental bridge, metal-ceramic

Chrom-Cobalt 95H25 by Zirkonzahn GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental bridge, metal-ceramic.

Prodent — Prodent Dental Technology (Shenzhen) Co., Ltd. · Class II
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE — Institut Straumann SA · Class II
Base metal alloy — Institut Straumann SA · Class II
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
CAD/CAM Pontic Zirconia — Beijing Yingguan Dental Technology Co., Ltd. · N
Base metal alloy — Institut Straumann SA · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zirkonzahn GmbH

Sources (2)

FDA UDI 806bdc8b-e4a9-4f07-bdd1-9aa2a640ebb7 34 fields · synced Jul 28, 2026
EUDAMED c8f3e8d6-2097-4bd6-af7f-769573862d1e 61 fields · synced Jul 28, 2026